JP5383837B2 - Articulation mechanism with links connected by flexible hinges - Google Patents

Description

(Related application)
This application claims the benefit of US Provisional Application No. 60 / 577,757, filed Jun. 7, 2004, the contents of which are hereby incorporated by reference.
(Background technology)

(Background of the Invention)
The present invention relates to an articulation mechanism and its use, such as steering, guiding and / or manipulating instruments and tools from a distance.

  The ability to easily steer, guide, and / or manipulate instruments and tools from a distance, especially when manual guidance by hand is not easy, or other instruments that can present other risks or dangers Or in a wide variety of industries and applications where it is desired to guide a tool. These include situations where the target site to which the tool or instrument is to be applied is difficult to access, such as certain surgical procedures or the manufacture or repair of mechanical devices, and even access to the target site by hand. And commercial and household applications that are restricted or impossible. Other situations may include, for example, industrial applications where the work environment is dangerous for the user, such as a work space exposed to dangerous chemicals. Still other environments can include, for example, police or military applications where the user may be at risk, such as placement of tools or equipment in dangerous or hostile locations.

  Using surgical procedures as illustrative examples, procedures such as endoscopy and laparoscopy are typically maneuvered in the target organ or tissue, or the target organ or Using instruments that are steered into the tissue. Examples of endoscopic procedures include sigmoidoscopy, colonoscopy, esophagogastroduodenoscopy, and bronchoscopy. Traditionally, the insertion tube of an endoscope is advanced by pushing forward and retracted by pulling backward. The tip of the tube can be guided by twisting and overall up and down and left and right movements. Because of this limited range of motion, steep angle maneuvers (eg, in the rectosigmoid colon) are often difficult, causing patient discomfort and increasing the risk of damaging surrounding tissues. Yes. Laparoscopy requires the installation of a trocar port according to anatomical landmarks. The number of ports will usually vary depending on the intended procedure, as well as the number of instruments required to achieve satisfactory tissue mobilization and surgical field exposure. There are many advantages of laparoscopic surgery, for example, less post-operative pain, early movement, less adhesion formation, but optimal organ retraction and traditional instrument maneuvering It is often difficult to do through a laparoscopic port. In some cases, these drawbacks can lead to increased surgical time and incorrect placement of elements such as staples and sutures. Steerable catheters are also well known in both diagnostic and therapeutic applications. Similar to an endoscope, the tip of such a catheter can only guide the movement to move the patient's vasculature to a roughly limited extent.

  Attempts already exist to design endoscopes and catheters with improved maneuverability. For example, Sato, US Pat. No. 6,069,086, Ailinger et al., US Pat. No. 5,057,086, Alotta et al., US Pat. An endoscopic instrument comprising a part is described. The wire is manipulated from the proximal end of the instrument by a rotating pinion (Sato), an operating knob (Ailinger et al.), A steering arm (Alotta et al.), Or a pulley mechanism (Sato). U.S. Pat. No. 6,053,009 to Boury et al. Discloses a steerable catheter having four wires extending through the wall of the catheter. Each wire terminates at various parts of the catheter. The proximal end of the wire protrudes loosely from the catheter, allowing the physician to pull the proximal end of the wire. The physician can shape the catheter by selectively placing the wire under tension, and can therefore steer the catheter.

  Each of the devices described above can be maneuvered from a distance, but the range of motion is generally limited. It is also believed that the steering mechanism is difficult to use, such as the Bowry et al. Catheter, where each wire must be pulled separately to shape the catheter. Furthermore, in the case of an endoscope or steerable catheter, for example using a knob and pulley mechanism, a significant amount of training is required to be proficient in maneuvering the device through the patient's body.

US Pat. No. 3,557,780 US Pat. No. 5,271,381 US Pat. No. 5,916,146 US Pat. No. 6,270,453 US Pat. No. 5,916,147

  Therefore, a device having excellent remote control so that a complicated shape can be moved with good controllability can advance and arrange instruments and tools more efficiently and accurately. Let's go. It would also be advantageous to have such a device with a more intuitive and handy user interface to achieve such excellent maneuverability. Such devices are considered to have a wide range of applications in instrument, tool guide, maneuver, and / or operation across multiple industries. Furthermore, such devices are themselves considered to have entertainment, entertainment and educational value.

(Summary of the Invention)
The present invention provides articulation mechanisms and components useful for various purposes such as, but not limited to, remote control of instruments and tools. Such instruments and tools include, but are not limited to, endoscopes, light sources, catheters, Doppler flowmeters, microphones, probes, retractors, dissectors, staples, clamps, and graspers. , Surgical or diagnostic instruments or tools, such as scissors or cutters, and ablation or cautery elements. Other instruments or tools in non-surgical applications include, but are not limited to, grippers, drivers, power tools, welders, magnets, optical lenses and viewers, light sources, electrical tools, audio / visual tools, A laser, a monitor, etc. are mentioned. Depending on the application, the articulation mechanism and components of the present invention may be easily scaled to accommodate numerous instruments and tool integration or adaptation to numerous instruments and tools. Articulation mechanisms can be used to steer these instruments or tools to the desired target site, and can be used to manipulate or facilitate such instruments and tools. be able to.

  In one variation of the invention, an articulation mechanism comprising a plurality of flexible segment pairs, each flexible segment of each pair being maintained in a spaced relationship with respect to the other flexible segment of the pair. An articulation mechanism is provided. The flexible segment has a unit composed of at least one link and at least one flexible hinge, and adjacent flexible segments in the mechanism are connected by the flexible hinge. The mechanism further comprises at least one cable set that connects at least one pair of flexible segments to each other, and moving one flexible segment of the connected pair allows the other possible pair of the pair. Relative motion corresponding to the flexure segment occurs. In further variations, additional cable sets are provided that connect additional pairs of flexible segments. A flexible segment can form the proximal and distal ends of the mechanism, and the movement of the proximal end of the articulation mechanism results in a corresponding relative movement of the distal end. Due to movement in two dimensions, the flexible hinges align in parallel. For movement in three dimensions, at least one flexible hinge of the mechanism is oriented at an acute angle with respect to at least one other flexible hinge of the mechanism. For maximum range of motion in three dimensions, at least one flexible hinge is oriented perpendicular to at least one other flexible hinge.

  In another variation of the invention, a flexible member is provided for use in an articulation mechanism. The flexible member includes one or more flexible segments connected together. The flexible member can be formed of any number of flexible segments and further means can be provided for connecting the members axially together in a vertical manner. The flexible member can be used to form an articulation mechanism according to the present invention, or can be incorporated into other mechanisms or devices. In one variant, the flexible member comprises a flexible hinge oriented in parallel. In other variations, the flexible member comprises at least one flexible hinge that is oriented at an acute angle with respect to at least one other flexible hinge. In a further variation, the at least one flexible hinge is oriented perpendicular to the at least one other flexible hinge.

  In a further variation of the present invention, a flexible segment is provided that can form a flexible member or articulation mechanism according to the present invention or that can be incorporated into a flexible member or articulation mechanism according to the present invention. The flexible segment includes a unit consisting of at least one link and at least one flexible hinge. In some variants, these flexible segments are designed with a flexible hinge that bends or bends at a particular predetermined position, which position has a unique effect on the cable extending through the segment. have. Specifically, these predetermined positions affect the relative tension of the cables passing through the flexible segment. This effect, also referred to as cable pull bias, can be negative, neutral, or positive. In one aspect, the predetermined bend position provides a negative cable pull bias that creates a sag in one or more cables passing through adjacent flexible segments when the mechanism is bent, i.e., articulated. Bring. In another aspect, the predetermined bending position provides a neutral cable pull bias in which cable slack is reduced or eliminated when the mechanism is bent, ie, when articulation occurs. In yet another aspect, the predetermined bending position is a positive cable pull that increases the tension of one or more cables associated with the flexible segment when the mechanism is bent, ie, when articulation occurs. Bring a bias. Each of these configurations is believed to have advantages depending on the specific application in front of the eye.

In a further aspect of the invention, a tool or instrument can be attached to or extended from the distal end of the articulation mechanism, or the articulation mechanism can be otherwise Can be incorporated into any instrument or tool. In the case of surgical applications, alternate examples for surgical or diagnostic use include, but are not limited to, endoscope, light source, catheter, Doppler flow meter, microphone, probe, sputum, dissector, staple , Clamps, grippers, scissors or cutters, and elements for ablation or cauterization. For other applications, such as, but not limited to, grippers, drivers, power tools, welders, magnets, optical lenses and viewers, light sources, electrical tools, audio / visual tools, lasers, light sources, monitors, Numerous tools or instruments can be envisioned as well. The type of tool or instrument, the method and position of attachment, and the application and usage are not limited thereto, but the present application and the owner are the same and are pending at the same time. Mention may be made of those described in US patent application Ser. Nos. 10 / 444,769 and 10 / 928,479, which are incorporated herein by reference.
For example, the present invention provides the following:
(Item 1)
A plurality of flexible segment pairs, each flexible segment of each pair being maintained in a spaced relationship with respect to the other flexible segment of the pair, wherein each flexible segment is at least one A plurality of flexible segment pairs comprising one link and at least one flexible hinge, wherein adjacent links of each flexible segment are connected by a flexible hinge; and
At least one cable pair connecting at least one pair of flexible segments such that moving one flexible segment of the pair causes relative movement corresponding to the other flexible segment of the pair; set
Having an articulation mechanism.
(Item 2)
The articulation mechanism of item 1, wherein the at least one flexible hinge is oriented perpendicular to the axis of the mechanism.
(Item 3)
The articulation mechanism of claim 1, wherein the at least one flexible hinge is oriented at an acute angle relative to the at least one other flexible hinge.
(Item 4)
The articulation mechanism according to item 1, wherein the at least one flexible hinge is oriented at right angles to the at least one other flexible hinge.
(Item 5)
Item 2. The articulation mechanism of item 1, wherein the flexible hinges are oriented parallel to each other.
(Item 6)
Connecting one or more additional pairs of flexible segments to each other such that moving one flexible segment of the additional pair causes relative movement corresponding to the other flexible segment of the additional pair 1 One or more additional cable sets
The articulation mechanism according to item 1, further comprising:
(Item 7)
The proximal and distal ends are formed by positioning each pair of flexible segments at the proximal and distal ends, respectively;
Item 2. The articulation mechanism of item 1, wherein movement of the proximal end causes relative movement corresponding to the distal end.
(Item 8)
Item 8. The articulation mechanism of item 7, wherein the corresponding relative movement of the distal end is reciprocal with respect to the movement of the proximal end.
(Item 9)
8. The articulation mechanism of item 7, wherein the corresponding relative movement of the distal end mirrors the movement of the proximal end.
(Item 10)
Surgical or diagnostic tool located at the distal end
The joint motion mechanism according to item 7, further comprising:
(Item 11)
Spacer elements disposed between flexible segment pairs
The articulation mechanism according to item 1, further comprising:
(Item 12)
The articulation mechanism of item 1, wherein the flexible segment pair comprises a passage for receiving and passing a cable set associated with an adjacent flexible segment pair.
(Item 13)
The articulation mechanism of claim 1, wherein the one or more flexible segments further comprise a passage for receiving an element of a surgical or diagnostic tool.
(Item 14)
The articulation mechanism of item 1, wherein the at least one flexible segment pair is not connected by a cable set.
(Item 15)
Item 13. The articulation mechanism of item 12, wherein the cable passages of each flexible segment are arranged in a cylindrical pattern, the diameter of the pattern being different between each pair of flexible segments.
(Item 16)
The articulation mechanism according to item 1, wherein each flexible hinge bends at a predetermined position with respect to a respective link connected by the flexible hinge.
(Item 17)
Item 17. The articulation mechanism of item 16, wherein the predetermined bending position provides a neutral cable pull bias.
(Item 18)
Item 17. The articulation mechanism of item 16, wherein the predetermined flexion position provides a negative cable pull bias.
(Item 19)
Item 17. The articulation mechanism of item 16, wherein the predetermined bending position provides a positive cable pull bias.
(Item 20)
The articulation mechanism according to item 1, further comprising a flexible segment formed integrally.
(Item 21)
A flexible member for use in an articulation mechanism, wherein adjacent links are connected by a flexible hinge.
(Item 22)
Item 22. The flexible member of item 21, wherein the at least one flexible hinge is oriented perpendicular to the axis of the member.
(Item 23)
Item 22. The flexible member of item 21, wherein the at least one flexible hinge is oriented at an acute angle relative to the at least one other flexible hinge.
(Item 24)
Item 22. The flexible member of item 21, wherein the at least one flexible hinge is oriented at right angles to the at least one other flexible hinge.
(Item 25)
Item 22. The flexible member of item 21, wherein the flexible hinges are oriented parallel to each other.
(Item 26)
At least one flexible segment comprising at least two links connected by at least one flexible hinge, the flexible hinge being bent at a predetermined position with respect to the two links
Item 22. The flexible member according to Item 21, further comprising:
(Item 27)
27. A flexible member according to item 26, wherein the bent position provides a neutral cable pull bias.
(Item 28)
27. A flexible member according to item 26, wherein the bent position provides a negative cable tension bias.
(Item 29)
27. A flexible member according to item 26, wherein the bent position provides a positive cable pull bias.
(Item 30)
27. A flexible member according to item 26, wherein the ends are provided with means for engagement.
(Item 31)
Item 31. The flexible member according to Item 30, capable of transmitting torque.
(Item 32)
A flexible segment comprising at least two links connected by at least one flexible hinge, the flexible hinge being bent at a predetermined position with respect to the two links.
(Item 33)
Item 33. The flexible segment of item 32, further comprising at least three links connected by two flexible hinges that bend in place relative to the links.
(Item 34)
33. A flexible segment according to item 32, wherein the flexible hinge is oriented perpendicular to the axis of the segment.
(Item 35)
34. A flexible segment according to item 33, wherein the flexible hinges are oriented at an acute angle with respect to each other.
(Item 36)
34. A flexible segment according to item 33, wherein the flexible hinges are oriented perpendicular to each other.
(Item 37)
33. A flexible segment according to item 32, wherein the bent position provides a neutral cable pull bias.
(Item 38)
33. A flexible segment according to item 32, wherein the bending position provides a negative cable pull bias.
(Item 39)
33. A flexible segment according to item 32, wherein the bent position provides a positive cable pull bias.
(Item 40)
A flexible segment in which at least two links are connected by two flexible hinges, and the flexible hinge bends at a predetermined position with respect to the two links.
(Item 41)
41. A flexible segment according to item 40, wherein the bending position provides a neutral cable pull bias.
(Item 42)
41. A flexible segment according to item 40, wherein the bent position provides a negative cable tension bias.
(Item 43)
41. A flexible segment according to item 40, wherein the bent position provides a positive cable pull bias.
(Item 44)
41. The flexible segment of item 40, further comprising an inner core and an outer cover.
(Item 45)
Wings that are placed between two flexible hinges and limit the bendable range of the hinges
41. The flexible segment of item 40, further comprising:
(Item 46)
Having a pair of opposing jaws movable relative to each other between a closed position and first and second open positions;
When the jaws move between the closed position and the first open position, they remain substantially parallel to each other and when they move between the first open position and the second open position, Surgical clamp to keep it non-parallel to it.
(Item 47)
Each jaw includes first and second slots that receive first and second pins extending from the jaw housing, wherein the first and second slots are mutually within a first length range of each slot. 49. The surgical clamp of item 46, wherein the surgical clamps are parallel and non-parallel to each other in the second length range of each slot.
(Item 48)
49. A surgical clamp according to item 46, wherein the opposing jaw surfaces are provided with grooves for receiving an energy source.
(Item 49)
A flexible member having at least one flexible segment comprising at least one link and at least one flexible hinge, the adjacent links of the flexible segment being connected by a flexible hinge;
A surgical or diagnostic tool attached to the distal end of the flexible member;
An elongate shaft attached to the proximal end of the flexible member; and
A distal side is connected to one or more flexible segments of the flexible member and a proximal side is received through the elongate shaft, the movement causing movement of the one or more flexible segments. One or more cables
Surgical device having.
(Item 50)
A distal portion having a plurality of flexible portions and a proximal portion comprising a plurality of links; and
Connecting the flexible portion of the distal portion to the link of the proximal portion to form a pair such that movement of one member of the pair causes a corresponding relative movement of the member of the pair At least one cable set
Having a catheter.
(Item 51)
The proximal portion further comprises a flexible member having at least one flexible segment comprising at least one link and at least one flexible hinge, wherein adjacent links of the flexible segment are allowed. 51. The catheter of item 50, connected by a flexible hinge.
(Item 52)
51. The catheter of item 50, wherein the proximal portion further has a handle and the plurality of links extend from the handle.

1A-1D show perspective views of articulation mechanisms according to one embodiment of the present invention, flexible segments connected by corresponding cable sets and having flexible hinges at right angles to each other.・ It has a pair. FIG. 1A shows the mechanism in a naturally unoperated configuration. 1B-1D show the mechanism for various operating states. 1A-1D show perspective views of articulation mechanisms according to one embodiment of the present invention, flexible segments connected by corresponding cable sets and having flexible hinges at right angles to each other.・ It has a pair. FIG. 1A shows the mechanism in a naturally unoperated configuration. 1B-1D show the mechanism for various operating states. FIG. 2A is a perspective view of a flexible member according to another embodiment of the present invention, comprising flexible segments having flexible hinges oriented perpendicular to each other . Figure 2B is a side view of the flexible segment of Figure 2A. FIG. 2C is a cross-sectional view of the flexible segment shown in FIG. 2B taken along the plane designated by line AA. 3A and 3B are a perspective view and a side view, respectively, of a flexible member according to still another embodiment of the present invention . Figure 3C is the flexible member of Figure 3A, a sectional view taken along the plane designated by line B-B. 4A and 4B are perspective and side views, respectively, of a flexible segment according to a further embodiment of the present invention . 4A and 4B are a perspective view and a side view of the flexible segment according to a further embodiment of the invention, respectively. FIG. 4C is a cross-sectional view taken along the plane specified by line CC for the flexible segment of FIG. 4A. 5A and 5B are a perspective view and a side view, respectively, of a flexible segment according to still another embodiment of the present invention. FIG. 5C is a cross-sectional view of the flexible segment of FIG. 5A taken along the plane designated by line DD. FIG. 6 is a side cross-sectional view of an articulation mechanism according to another embodiment of the present invention, illustrating the scaling of motion between the proximal and distal ends. FIG. 7 is a side cross-sectional view of an articulation mechanism according to yet another embodiment of the present invention, illustrating another scaling of motion between the proximal and distal ends. FIG. 8A is a perspective view of a surgical instrument incorporating a grasping tool and an articulation mechanism according to one embodiment of the present invention . FIG. 8B is an enlarged view of the distal end of the instrument of FIG. 8A showing the gripping tool in more detail. 9A and 9B are views and cross-sectional views, respectively, of the end of the gripping tool shown in FIG. 8B in the closed position, the cross-sectional view of FIG. 9B being along the plane specified by line 9B-9B of FIG. 9A. It has been obtained. FIGS. 10A and 10B are respectively an end view and a cross-sectional view of the gripping tool shown in FIG. 8B in a first open position (chins remain parallel), the cross-sectional view of FIG. Along the plane specified by the line 10B-10B. FIGS. 11A and 11B are a view and a cross-sectional view, respectively, of the end of the gripping tool shown in FIG. 8B in the second open position (the jaws are moving to a non-parallel position). The illustration is taken along the plane specified by line 10B-10B in FIG. 9A. FIG. 12 is a perspective view of a flexible segment according to still another embodiment of the present invention. 13 is an exploded view of the flexible segment of FIG. 12, showing the inner core and outer cover forming the flexible segment of FIG. 14A and 14B are side and cross-sectional views, respectively, in a straight unbent configuration of a flexible segment according to a further embodiment of the present invention. The cross-sectional view of FIG. 14B is taken along the line designated by 14B-14B of FIG. 14A. 15A and 15B are side and cross-sectional views, respectively, in the bent configuration of the flexible segment of FIGS. 14A and 14B. The cross-sectional view of FIG. 15B is taken along the line designated by 15B-15B of FIG. 15A. FIG. 16A is a perspective view of a catheter incorporating an articulation mechanism according to one embodiment of the present invention . FIG. 16B is an enlarged view of the distal end of the catheter of FIG. 16A.

(Detailed description of the invention)
The articulation mechanism according to the present invention broadly includes a plurality of flexible segment pairs and at least one cable set connecting at least one individual flexible segment pair. In some embodiments, the articulation mechanism can be constructed of a flexible member that is made of flexible segments and can have a variable number of links. As used herein, the term “link” is an individual part of the mechanism, flexible member, or flexible segment, and other individual parts of the mechanism, flexible member, or flexible segment. A part that can move relative to a part. The link is typically but not necessarily cylindrical. The links are generally aligned along the longitudinal axis of the mechanism, flexible member, or flexible segment. Adjacent links of the mechanism, flexible member, or flexible segment are connected by a flexible hinge. Furthermore, the articulation mechanism, the flexible member, or the link at the end of the flexible segment can be secured to another aspect of the mechanism or a tool attached to the mechanism, or other mechanism of the mechanism It can be incorporated into an embodiment or a tool attached to the mechanism. The term “flexible hinge” refers to an individual site extending from a link and capable of bending. The flexible hinge is typically, but not necessarily, oriented perpendicular to the longitudinal axis of the mechanism, flexible member, or flexible segment. Typically, but not necessarily, the link and the flexible hinge are integrally formed. A “flexible segment” typically includes one or more adjacent links connected by a flexible hinge. A flexible segment that can move in two dimensions with a single degree of freedom can have only one flexible hinge connecting two links. A flexible segment that can move in three dimensions in two degrees of freedom can have two flexible hinges arranged at an acute angle to each other to connect the three links. For the maximum three-dimensional range of motion, the angle is a right angle. The flexible segment can provide a flexible member or a component piece of an articulation mechanism. A “flexible segment pair” refers to a flexible segment located at one end of the mechanism and corresponding to another flexible segment located at the other end of the mechanism. The articulation mechanism according to the present invention may comprise a plurality of flexible segments that are members of separate pairs. The flexible segments are generally arranged to form a proximal end and a distal end, with one flexible segment in each pair located at the proximal end and the other flexible segment at the distal end. To position. In order to achieve maximum freedom of movement in three dimensions, at least one flexible hinge of the mechanism is arranged at right angles to at least one other hinge of the mechanism. However, the present invention also contemplates configurations in which the flexible hinges are arranged in parallel or are offset at any acute angle.

  Cable sets can connect individual pairs of flexible segments to each other such that moving one flexible segment of the pair causes movement corresponding to the other flexible segment of the pair. . As used herein, the term “active flexible segment” or “active flexible segment pair” refers to flexible segments that are directly connected to each other by a cable set. The term “spacer flexible segment” or “spacer flexible segment pair” refers to flexible segments that are not directly connected by a cable set. However, spacer flexible segments can be placed between the active flexible segments to pass a cable set connecting the active flexible segments. The ability to manipulate the active flexible segment pair allows the mechanism to easily form complex three-dimensional configurations and shapes, as described in more detail below. In conventional articulation devices that rely on cable sets or wires passing through links without being connected, it is difficult to obtain such complex shapes. This is because such devices are typically designed so that the steering cable or wire passes through each link and terminates at the most distal link. That is, all segments are bent together in response to the movement of the wire or cable set, typically in a curved arched appearance.

  Besides the formation of complex shapes, according to the present invention, the mechanism is constrained by restraining the operated active flexible segments so that they can resist movement due to forces applied from the side. The rigidity of can be increased. For a given flexible segment pair, when the segment pair is manipulated to achieve the desired shape and one segment of the pair is secured to the desired shape, the other segment of the pair is loaded Can be considered fully constrained if it can withstand and maintain the desired shape when no load is applied. In order to fully constrain a one-degree-of-freedom flexible segment having two links and one flexible hinge, at least two cables are required. For a two-degree-of-freedom flexible segment having three links and two flexible hinges (directed at an acute or right angle to each other), at least three cables are required to fully constrain the segment Needed. This is not always the case with conventional articulation devices. The spacer flexible segment is not constrained in this way, and providing such an unconstrained spacer flexible segment may be advantageous in many situations where it is desirable to make a portion of the operated mechanism less rigid.

  The terms “instrument” and “tool” are used interchangeably herein and refer to a device that is normally handled by a user to accomplish a particular purpose. For illustrative purposes only, the articulation mechanism of the present invention is used to guide, operate, and / or operate surgical or diagnostic tools and instruments from a distance in a body region that is accessed from a distance. Explain in the context of usage. As already mentioned, other uses of articulation mechanisms besides surgical and diagnostic applications can be envisaged and will be apparent to those skilled in the art. Broadly, such applications include any situation in which manual guidance by hand is not easy, or where it is desired to guide an instrument or tool to a work space that may present other risks or dangers. These include, but are not limited to, industrial guides such as guides for tools, probes, sensors, etc. into tight spaces, or precise manipulation of tools from a distance, for example for assembly or repair of machinery. Applications are listed. Furthermore, they include commercial and household situations where the target site to which the tool or instrument is to be applied is difficult to access. Other situations may include, for example, industrial applications where the work environment is dangerous for the user, such as a work space exposed to dangerous chemicals. Still other situations may include, for example, police or military applications where the user may be at risk, such as placement of tools or equipment in dangerous or hostile locations. Still other uses include applications where simply complex remote control is desired. They include use in entertainment or entertainment such as toys or games, for example, remote control of puppets, dolls, figurines and the like.

  Turning to the embodiment shown in FIGS. 1A-1D, articulation mechanism 100 includes a plurality of flexible segments that form a proximal end 121 and a distal end 122. Flexible segments 111 and 112, 113 and 114, 115 and 116, 117 and 118, and 119 and 120 are each members of an individual pair, and one flexible segment (111, 113, 115, 117, or 119) is located at the proximal end 121 and the other (112, 114, 116, 118, or 120) is located at the distal end 122. As shown, the flexible segment 111 at the proximal end 121 is formed of links 101, 103, and 105 connected by flexible hinges 107 and 109 oriented at right angles to each other. Cable passages 123 are located around each link and extend through each link to allow the cable set to pass and connect. Further, the flexible segment is a central that extends through the longitudinal axis of the flexible segment to accommodate additional cables, wires, optical fibers, or other similar elements related to the desired tool or instrument used with the mechanism. A passage 124 is provided. The paired flexible segments 112 at the distal ends 122 are similarly formed by links 102, 104, and 106 connected by flexible hinges 108 and 110 oriented at right angles to each other, again with similar cable paths and centers. It has a passage. The remaining flexible segments (113, 115, 117, and 119, and 114, 116, 118, and 120) at both the proximal and distal ends are the last link of one segment as the next segment. It has the same structure while functioning as the first link. Further, as shown, each flexible hinge is oriented at a right angle to the adjacent hinge. As already mentioned, a flexible segment with such a configuration can move in two degrees of freedom and can move in three dimensions. The proximal flexible segments (111, 113, 115, and 119) are routed to the distal flexible segments (112, 114, 116, and 120) of cables 131, 133, 135, and 139, respectively. Connected by set. Therefore, these flexible segment pairs are active flexible segments. Flexible segments 117 and 118 are not directly connected by a cable set and thus function as spacer segments. This mechanism provides additional spacing between the proximal flexible segment and the distal flexible segment, so that a spacer element 125 is further disposed between the proximal end 121 and the distal end 122. I have. The spacer element is optional and can be of any length suitable for the intended application. The spacer element houses all the cables connecting the flexible segment pair, as well as additional cables, wires, optical fibers, or other similar elements related to the desired tool or instrument used with the mechanism. It is configured as follows.

  Each active flexible segment at the proximal end of the articulation mechanism is connected to a corresponding active flexible segment at the distal end by two or more cables. Each cable set can be comprised of at least two cables. As already mentioned, the movement of one active flexible segment pair can be controlled independently of any other flexible segment pair by a corresponding cable set. For example, in some variations, the cable set comprises three cables spaced 120 degrees apart. Using a set of three cables to connect an active flexible segment having at least one flexible hinge disposed at right angles to at least one other flexible hinge; Each of the active flexible segment pairs can be manipulated or moved in three degrees of freedom, independently of any other active pair. These three degrees of freedom include up and down motion, left and right motion, and rotational or “rollover” motion. By combining multiple active flexible segments, multiple degrees of freedom are achieved, allowing the articulation mechanism to be shaped into a variety of complex shapes. For example, the variant shown in FIGS. 1A-1D has a total of four active flexible segment pairs, each independently connected by a set of three cables, and motion in 12 degrees of freedom. Is possible. Such a large number of degrees of freedom is not possible in a typical conventional mechanism where only one set of cables is used to manipulate the linkage of the mechanism.

  As already mentioned, the flexible segment further comprises a passage for the cable connecting the active flexible segment pair as shown. If desired, further cables, wires, optical fibers, flexible endoscopes, and the like can be extended through a central passage provided in the flexible segment. It is also possible to provide a passage so that the fluid delivery tube can pass. In addition, the flexible segment is connected to the outside of the flexible segment for attaching other elements such as energy sources (for ablation or coagulation) or optical fibers or a flexible endoscope to the distal end of the articulation mechanism It can be designed with a connection channel. Two or more flexible segments can be provided with connection channels to extend the connection channels from the distal end to the proximal end of the mechanism.

  Referring to FIG. 1A, a cable secured to the proximal active flexible segment passes through the spacer 125 and leads to the corresponding distal active flexible segment of the pair. As shown in FIGS. 1B and 1C, moving the proximal active flexible segment results in the opposite mutual movement of the distal active flexible segment. In other variations, the cable can be twisted or rotated 180 ° as it extends through the spacer 125 so that the mutual movement of the distal end 122 is a mirror image. The articulation mechanism of the present invention can be configured with cables twisted in any amount between 0 ° and 360 ° to provide mutual motion in the range of 360 °.

  The articulation mechanism may include spacer flexible segments, ie, flexible segments that are not connected by individual cable sets (eg, 117 and 118 in FIGS. 1A-1D). These flexible segments can be inserted between the active flexible segments at either the proximal end or the distal end, or both, and cannot be operated individually, but adjacent active flexible segments It functions as a flexible segment that allows the cable set to pass through. A spacer flexible segment may be desired to provide additional length at the proximal and / or distal ends of the mechanism. By additionally providing a spacer flexible segment at one end of the mechanism (or by providing a larger number of spacer flexible segments than the other party), it is possible to make proportional movement expansion or movement of the corresponding other end. . For example, with a spacer flexible segment at the proximal end (or with more spacer flexible segments than the counterpart), the user is larger at the proximal end to achieve the desired motion at the distal end. You will have to make a move. This is finely controlled, for example, in situations where the user may not have the necessary dexterity to perform the desired procedure without such distal end movement or proportional expansion of movement. It may be convenient in situations where a good exercise is desired. Alternatively, a spacer flexible segment may be provided at the distal end (or a larger number of spacer flexible segments than the counterpart), in which case the degree of movement of the distal end is determined by the movement of the proximal end. And is greater than the degree of proximal end movement, which may also be desirable in certain applications. In addition to the above, proportional expansion of movement or motion can be achieved by increasing or decreasing the radius of the cable path pattern of the active flexible segment or spacer flexible segment at either the proximal or distal end. Yes, but this will be explained in more detail later.

  As described above, complex motions including upward, downward, right, left, diagonal, and rotational motions can be achieved by forming a pair of active flexible segments connected by separate cable sets. . For example, in the variant shown in FIG. 1B, the most distal active flexible segment 112 at the distal end remains stationary with all other flexible segments remaining at the proximal end of the proximal end. It can be moved by manipulating the side flexible segment 111. Furthermore, the proximal segment 111 can be manipulated such that the most distal flexible segment 112 describes a right cone about the longitudinal axis Z1 of the mechanism, and the base of such right cone Increase the length of the flexible hinge, increase the cable flexibility, and add a spacer flexible segment between the flexible segment 112 and the next adjacent active flexible segment. It becomes large by factors such as. At least as importantly, the proximal segment 111 can be rotated or “rolled” about its own axis, as indicated by Z3 in FIG. The torque transmitted through to the distal segment 112 causes the segment 112 to rotate about the axis of the segment 112, as indicated by Z2 in FIG. 1B.

  As shown in FIG. 1C, the most proximal active flexible segment 120 at the distal end keeps all other flexible segments from moving while the distal most distal end at the proximal end. Only the active flexible segment, ie, the flexible segment 119, is driven. By manipulating the proximal end in this configuration, the distal end has a larger cone diameter base cone than the one described above with respect to FIG. I can draw. Again, the proximal end can be rotated or “rolled” about its own axis, resulting in torque being transmitted through the mechanism to the distal end.

  Although several segmental motions are depicted in FIGS. 1B-1D, other complex three-dimensional motions can be achieved, including upward, downward, right, left, diagonal, and rotational motions. Is possible. For example, FIG. 1D shows the distal end 122 of the articulation mechanism 100 having a plurality of curvatures along the length, each of which is oriented in an independent direction. As already mentioned, the articulation mechanism 100 of FIGS. 1A-1D has four active flexible segment pairs, each of which is connected by a cable set having three cables, with 12 degrees of freedom. However, other configurations of flexible segment pairs and cable sets can easily achieve similar complex motions and shapes. The ability of the mechanism to bend simultaneously in different directions and create an active and complex configuration drives each active flexible segment pair independently and independently controlled by a corresponding cable set Is brought about by.

  Turning to FIGS. 2A-2C, the flexible member 200 is a series of links 202, 204, 206, 208, 210, 212 connected by flexible hinges 231, 232, 233, 234, 235, and 236, respectively. , And 214 formed by flexible segments 216, 218, and 220. Both ends of the flexible member end with links 202 and 214. The end link 202 includes a cylindrical recess 223 and a hexagonal boss 225 facing away from the end link 214. On the other hand, the end link 214 includes a hexagonal socket 224 facing away from the end link 202. As shown, the flexible hinges 231, 233 and 235 are oriented at right angles to the flexible hinges 232, 234 and 236. As shown, the link further includes a passage 228 that houses the individual cable sets that control the link. This member is designed so that the cable passes through the cable path of the link and terminates at the end link 202 of the flexible segment 216 and is attached to the end link 202. Specifically, the cable can exit the passage 228 at the exit point 229 and be secured to the recess 223 in the link 202. Thus, the flexible segment 216 can function as an active flexible segment while the remaining flexible segment is a spacer flexible segment. Alternatively, the cable set can terminate at any one of the other flexible segments and any other flexible segment as the active flexible segment. Also, although the cable passages 228 are shown arranged in a circular pattern, such patterns are not important because each passage can be arranged at any radial position on the member. A central passage 227 extends axially through the flexible member to accommodate additional elements of any tool or instrument that can be combined with the flexible member or articulation mechanism comprising the flexible member. Alternatively, a similar passage may be provided at any other radial position of the member including the peripheral region. The flexible member can be incorporated into all or part of the proximal and distal ends of the articulation mechanism according to the invention, or the flexible member can be a proximal end and a distal end of the articulation mechanism according to the invention. Of all or part of it.

  The flexible hinge system has various important advantages. One is manufactured because the flexible segment, flexible member, or articulation mechanism, or part thereof, can be manufactured as a single continuous piece with multiple links connected by a flexible hinge. And is easy to assemble. Furthermore, multiple flexible segments or members of the same or different configuration can be easily connected together to produce a wide variety of articulation mechanisms, and the characteristics of such articulation mechanisms are, in part, Depends on the flexible segment or member used as the component. In the embodiment shown in FIGS. 2A-2C, a plurality of flexible members can be connected to each other by mutual bosses 225 and sockets 224, although those skilled in the art can achieve the same purpose. It will be appreciated that there are various interstructures. A further advantage provided by the flexible hinge system is an improved torque transmission capability along the mechanism. In a mechanism in which individual links are connected only by a cable set, torque is not easily transmitted because a certain amount of twisting occurs in the cable due to the applied force. Furthermore, the flexible hinge system allows an axial load along the mechanism to be applied without compromising operation. Even under axial loads, the articulation of the mechanism is still smooth and easy. This is because the individual links are in frictional contact with each other, and the axial load increases the friction between the links and restricts movement, or in some other cases the links are completely “fixed”. It does not apply to that mechanism.

  To achieve maximum freedom of movement, at least one flexible hinge of the mechanism, flexible member, or flexible segment is oriented perpendicular to at least one of the other flexible hinges. Yes. However, in applications where freedom of movement may be more limited, the flexible hinges need not necessarily be orthogonal. In the embodiment shown in FIGS. 1 and 2, the continuous hinges are orthogonal to each other, but the invention is such that two or more continuous hinges are oriented parallel to each other, or from 0 ° to 90 °. Other configurations are envisioned, such as configurations that are offset from each other.

  Turning to FIGS. 3-5, an embodiment of a flexible segment is shown that curves or deflects in place relative to an adjacent link to which a flexible hinge is connected. The links otherwise have the same overall diameter, the same diameter or distance between the cable passages, and the same gap between the links. When incorporated into an articulation mechanism, a predetermined deflection position between links can have a positive, neutral, or negative influence or bias on the relative tension of the cable passing through the link. More particularly, when a flexible segment bends due to an operating force applied by a cable along one side of the link of the segment, the relative tension of the cable passing through the opposite side of the link is positive, negative, or Can be influenced by a neutral aspect. This action, or bias, can also be referred to as “cable pull bias”. A flexible segment in which the cable pulls when the segment links are articulated or where the cable pull increases can be referred to as having a “positive bias”. On the other hand, a flexible segment in which cable pull is reduced or the cable sag when the segment links are articulated can be referred to as having a “negative bias”. A flexible segment with minimal cable pull and cable sag can be referred to as having a “neutral bias”. Depending on the application, such positive, neutral or negative effects may be advantageous. Certain predetermined flexure positions to achieve positive, neutral, or negative cable pull bias are given, such as the diameter of the cable path pattern, the gap between the links where the cable is exposed, and the maximum deflection angle of the link. Depends on the specific dimensions of the link pair and connecting hinge. These particular predetermined deflection positions can be measured as a specific offset (positive or negative) relative to the link surface where the cable emerges from or exits the cable passage. In operation, when the flexible segment links are manipulated to the desired position or configuration, the flexible hinge between the two given links will bend or bend, and the two links will be centered around the hinges. Bends or curves away from each other or away from each other. Under the neutral bias configuration, the distance that a given cable path exit point on one link moves toward the corresponding cable path exit point on the other link is the opposite of the opposite side of the link. Equal to the distance that the cable path exit point moves away from the corresponding cable path exit point on the other link. However, the combinatorial distance between the two respective sets of cable path exit points remains constant regardless of whether the segment is deflected, which is important for maintaining a neutral cable bias. If the distances of such combinations are not equal, increased cable sagging or tension can occur. Specifically, when the link is deflected, cable pull may occur if the distance of the combination between the set of opposing passage exit points is greater than the distance of the combination in a straight unbent position. On the other hand, when bending or bending, the cable may sag if the distance of the combination between the set of opposing passage exit points is reduced compared to a straight unbent position.

In the embodiment shown in FIGS. 3A-3C, the flexible segment 240 includes a flexible hinge 246 connecting the links 244 and 245. The link further includes a cable passage 248. The links have a cable path pattern diameter D and are separated by a gap G between the links where the cable is exposed. The link has a maximum deflection angle T about the hinge 246. In the situation where D is 5 times G and T is 20 °, the desired predetermined deflection position for a neutral cable pull bias is an offset O ₁ of 1/100 × D, which is the fact Above is the surface 247 of the link 245 where the cable emerges from the cable passage, i.e. exits the cable passage, or is near the surface 247. In other words, in this situation, the flex position is aligned with or approximately aligned with the surface portion of the link 245 where the cable emerges or exits. In this particular configuration, cable sag is minimized over the range of segment motion. By minimizing cable slack, the mechanism can maintain its shape over a range of motion and can withstand reaction forces that add to the mechanism and impair shape accuracy. This will be useful in most applications. A flexible hinge configuration that minimizes cable slack can be referred to as having a “neutral bias”.

In the embodiment of FIGS. 4A-4C, the flexible segment 260 has a flexible hinge 266 with a predetermined deflection position positioned between two adjacent links 264 and 265. Links 264 and 265 have cable passages 268. In this configuration, the flexible hinge has a positive offset O ₂ with respect to the surface 267 of the link 265. In the situation of dimensions D, G, and T as described above, this deflection position results in a negative cable pull bias. That is, when the segments bend at these links due to the manipulation forces applied by the cable along one side of the link, a sag is typically created in the cable along the opposite side of the link. In some applications, the generation of such sag may be preferred because it reduces the stiffness of the device in the area and limits the resistance to reaction forces distributed along the area. Examples where this may be desirable include moving the mechanism through or around sensitive or fragile body structures. A flexible hinge that allows some degree of cable deflection can be referred to as having a “negative bias”.

In FIGS. 5A-5C, the flexible segment 280 includes a flexible hinge 286 that connects links 284 and 285. Again, links 284 and 285 are provided with cable passages 288. In this configuration, the deflection position has a negative offset O ₃ with respect to the surface 287 of the link 285. That is, the deflection position is below the surface of the link 285 where the cable appears or the cable exits. In the situation of dimensions D, G, and T as described above, this deflection position results in a positive cable pull bias. That is, when the segments bend at these links due to the manipulation forces applied by the cable along one side of the link, tension is typically created in the cable along the opposite side of the link. In some applications, the generation of such tensions may be preferred because it increases the rigidity of the device in the area and resists the applied reaction force. In addition, such tension can provide resistance to further bending of the mechanism and provide feedback to the user. An example where this may be desirable is in applications where protection is important against overbending of the mechanism, ie “overbending”. A flexible hinge having this configuration that creates additional tension on the cable can be referred to as having a “positive bias”.

  FIG. 6 shows another embodiment of the present invention, in which the articulation mechanism 300 includes a proximal end 321 and a distal end 322 and a spacer element 325 disposed therebetween. A distal end 322 includes flexible segments 316, 318, 320 formed by connecting a series of links 302, 304, 306, 308, 310, and 312 by flexible hinges 317, 319, 321, 323, and 325, respectively. 322, and 324. Proximal end 321 includes a flexible segment 314 formed by connecting links 301 and 303 by a flexible hinge 315. As shown, the flexible hinges are all oriented parallel to each other along the longitudinal axis of the unactuated mechanism (as represented by axis Z). In this manner, the mechanism can provide a two-dimensional motion rather than a three-dimensional motion. In addition, the link includes a passageway that accommodates cables 331 and 332 that make up a cable set that controls the operation of the mechanism. As described above, the mechanism is designed so that the cable passes through the cable path of the link. The cable is secured to the end link 302 distal to the flexible segment 316 and the end link 301 proximal to the flexible segment 314. Thus, flexible segments 316 and 314 function as an active flexible segment pair, with the remaining flexible segments being spacer flexible segments.

  FIG. 6 shows the articulation mechanism 300 in a driven or operated state. As can be seen, the flexible segment 314 proximal to the proximal end 321 is bent by an angle W. With the addition of a spacer segment at the distal end 322, the distal end as a whole bends by the same angle W, but the angle between each flexible segment is smaller so that the cumulative angle matches the angle W. It has become. On the other hand, the moving distance Y of the distal end 322 relative to the original axis Z of the mechanism is proportional to the moving distance X of the distal end 321 relative to the axis Z and is larger than the moving distance X. This explains how the addition (or removal) of spacer segments results in a larger (or smaller) lateral displacement while achieving the same overall bending angle.

  FIG. 7 illustrates a further embodiment of the present invention in which the articulation mechanism 350 has a proximal end 371 and a distal end 372 separated by a spacer element 375. Distal end 372 includes a flexible segment 362 formed by connecting links 352 and 354 by a flexible hinge 356. The proximal end 371 includes a flexible segment 361 formed by connecting links 351 and 353 by a flexible hinge 355. Again, all of the flexible hinges are oriented parallel to each other along the longitudinal axis (not shown) of the unactuated mechanism, again resulting in a two-dimensional motion rather than a three-dimensional motion. Further, the link has a passage for receiving cables 381 and 382 constituting a cable set for controlling the operation of the mechanism. Again, this mechanism is also designed so that the cable passes through the cable path of the link. The cable is secured to the end link 352 distal to the flexible segment 362 and the end link 351 proximal to the flexible segment 361. Thus, flexible segments 362 and 361 function as an active flexible segment pair. As shown, the diameter K between the cable passages of the links 351 and 353 at the proximal end is larger than the diameter J of the corresponding links 352 and 354 at the distal end.

As shown, the articulation mechanism 350 is in a driven or operated state. As can be seen, the flexible segment 361 proximal to the proximal end 371 is bent by an angle H. However, the distal flexible segment 362 is bent at a larger angle P. This is because the diameter between the cable passages is different between the proximal link and the distal link. The change in the angle of bending is approximately proportional to the difference in diameter, and the angle P is proportional to the angle obtained by multiplying the angle H by the ratio of the two diameters (ie, P∝H × (K / J)). Thus, for any two link pairs, this difference can be expressed in terms of the resulting swing angle that occurs when the link is manipulated for an unrotated state. That is, for a given link pair L ₁ and L _{2 with} different cable path location radii R ₁ and R ₂ respectively from the center axis of the link and R ₂ > R ₁ , L ₁ is angle _{When the} head is swung to ₁ , the corresponding link L ₂ has a swing angle of A ₂ = A ₁ × sin ⁻¹ (R ₁ / R ₂ ) as a result. This illustrates how increasing or decreasing the diameter or radius of the cable path pattern can proportionally increase or decrease the bending or deflection angle of the mechanism. This is because a small bend angle at the proximal end operated by the user can result in a large bend angle or bend at the distal end, and movement of the distal end to position and / or manipulate a surgical tool or instrument. It can have important ergonomic applications, such as surgical applications that can expand or augment. In other applications, it may be desirable for the proximal end that the user manipulates to have a greater bending angle than the distal end.

  Further, the link may have any size and shape depending on the purpose within a range not inconsistent with the above-described examination. In surgical applications, the dimensions and shape of the link are typically determined by factors such as the age of the patient, the body structure of the area of interest, the intended use, and physician preference. The link is not required, but is usually cylindrical, and as already mentioned, is provided with a passage for the cable connecting the flexible segment pair, and further to the desired tool or instrument used with the mechanism. A passage is provided for the passage of additional cables, wires, optical fibers, or other similar elements involved. The diameter of the passage is usually slightly larger than the diameter of the cable, creating a slip fit. In addition, the link may include one or more channels for receiving elements of attachable surgical instruments or diagnostic tools or for passing cables that operate them. The link typically can have a diameter of about 0.5 mm to about 15 mm or more depending on the application. In endoscopic applications, typical diameters may range from about 2 mm to about 3 mm for small endoscopic instruments, and about 5 mm to about 5 mm for endoscopic instruments of medium size. It may be in the range of about 7 mm, and may be in the range of about 10 mm to about 15 mm for large endoscopic instruments. For catheters, the diameter may range from about 1 mm to about 5 mm. The overall length of the link usually depends on the desired bend radius between the links and can vary.

  Articulation mechanisms, flexible members, and flexible segments are known in the art and can be formed of several materials that may vary depending on the application. For ease of manufacture, for example, polyethylene or copolymer thereof, polyethylene terephthalate or copolymer thereof, nylon, silicone, polyurethane, fluoropolymer, polyvinyl chloride, and combinations thereof, or known in the art Injection moldable polymers can be used, such as other suitable materials.

  In surgical applications, a lubricious coating can be placed on the link or segment if desired to facilitate advancement of the articulation mechanism. Examples of the lubricious coating include hydrophilic polymers such as polyvinyl pyrrolidone, fluoropolymers such as tetrafluoroethylene, and silicone. Radiopaque markers may be provided in one or more segments to indicate the position of the articulation mechanism by radiographic imaging. Usually, the marker is detected by fluoroscopy.

  The diameter of the cable varies depending on the application. For surgical applications in general, the cable diameter can range from about 0.15 mm to about 3 mm. For catheter applications, typical diameters may range from about 0.15 mm to about 0.75 mm. For endoscopic applications, typical diameters may range from about 0.5 mm to about 3 mm.

  The flexibility of the cable can vary, for example, depending on the type and knitting method of the cable material, or by physical or chemical treatment. Usually, the stiffness or flexibility of the cable is adjusted according to the stiffness or flexibility required by the intended use of the articulation mechanism. Cables include, but are not limited to, nickel-titanium alloys, stainless steel or any alloy thereof, superelastic alloys, carbon fibers such as polyvinyl chloride, polyoxyethylene, polyethylene terephthalate and other polyesters, polyolefins Single-wire or multi-wire made from polymers such as polypropylene, and copolymers thereof, biocompatible materials such as nylon, silk, and combinations thereof, or other suitable materials known in the art It may be a wire.

  The cable is commonly owned and co-pending with the present application and is incorporated herein by reference in its entirety, US patent application Ser. Nos. 10 / 444,769 and 10/928. Can be attached to the active pair of flexible segments according to methods known in the art, such as the use of adhesives, brazing, soldering, welding, and the like.

  The multiple articulation mechanisms and flexible members shown in the accompanying drawings have a certain number of flexible segments and flexible segment pairs, but this is simply an individual mechanism or possible. This is for the purpose of illustrating the relationship between the flex segment components. Any number of flexible segments and flexible segment pairs can be used depending on factors such as the intended use of the articulation mechanism and the desired length.

  The natural configuration of the articulation mechanism, flexible member, or flexible segment is usually straight, but if desired, the mechanism, flexible member, or flexible segment has a pre-formed bend. Can be manufactured as follows. If it is desired to maintain a specific curvature or other complex configuration at the distal end of the articulation mechanism, for example, the present application and the owner are the same and pending at the same time, the entire The mechanism can be “locked” in place according to the manner described in US patent application Ser. Nos. 10 / 444,769 and 10 / 928,479, which are hereby incorporated by reference. . For example, a malleable tube that can be slid over the proximal segment can be shaped to hold the proximal segment and thus the corresponding distal segment can be configured with a particular configuration. Can be held in. For example, the user may move the mechanism to a desired target position and “fix” the mechanism to that position, for example, operate a tool associated with the mechanism, or engage in a completely separate procedure. In some cases, it is considered convenient. The term “malleable” means that the tube is sufficiently rigid so that it can be molded while being sufficiently rigid to maintain the shape after molding. In other variations, a fixation rod to one or more connecting channels extending through the flexible segment or segment to “fix” the proximal and distal segments of the articulation mechanism in place Can be inserted. The fixation rod may be a malleable metal rod that can be molded and inserted into the connection channel to set the proximal and distal segments in a particular configuration, or A pre-shaped form may be provided. In a further variation, the flexible segment or member itself can be formed of a malleable material that retains its shape after being manipulated into the desired configuration.

  As already mentioned, the articulation mechanism of the present invention can be applied to surgical or diagnostic instruments from a position outside the patient's body, in a natural linear configuration, or after various manipulations at the proximal end. It can be used to guide the tool within the patient's body area or to a target site within the patient's body area. After proper insertion, moving the proximal end of the mechanism causes mutual movement at the distal end. Furthermore, the directional motion that occurs at the distal end can be reversed, mirror symmetric, or otherwise, depending on the degree of rotation of the proximal end relative to the distal end. Can do. Also, other conventional interfaces where the proximal end is a user interface for controlling the steering and steering of the distal end, for example relying on a pulley or knob to control the steering of the wire It provides a user interface that is convenient and easy to use compared to the steering mechanism. This user interface is based on, for example, the shape and directional movement of the distal end of the mechanism located within the patient's body based on the shape after manipulation of the externally located proximal end user interface. For example, the user can easily grasp visually. In a further variation, the flexible segment or member itself may be formed of a malleable material that retains its shape after being manipulated into the desired configuration.

  Articulation mechanisms include, but are not limited to, blood vessels (intracranial blood vessels, large blood vessels, peripheral blood vessels, coronary arteries, aneurysms, etc.), heart, esophagus, stomach, intestine, bladder, ureter, fallopian tube, bile duct, etc. Can be used for remote manipulation of surgical instruments, diagnostic tools, various catheters, etc. to hollow or tufted organs and / or tissues such as large and small airways. In addition, surgical instruments that move articulation mechanisms to solid organs and / or tissues such as, but not limited to, skin, muscle, fat, brain, liver, spleen, and benign or malignant tumors. Diagnostic tools, various catheters, etc. can be used to guide from a distance. Articulation mechanisms can be used in mammalian subjects, including humans (mammals include, but are not limited to, primates, farm animals, sport animals, cats, dogs, rabbits, mice, and rats). ).

  Turning to FIGS. 8-12, there is shown an embodiment of the present invention that incorporates an articulation mechanism comprising a flexible segment into a surgical instrument. FIG. 8A shows a surgical grasping instrument 400 comprising an elongate shaft 405 separating a proximal flexible member 406 and a distal flexible member 407. The flexible member is as described above and includes a plurality of cables combined with individual flexible segments so that movement of the proximal end results in corresponding movement of the distal end. Pivoting arms 403 and 404 are located at the proximal end of the proximal flexible member 406 and can be pivoted toward and away from each other. It has a standard ratchet handle interface. The distal end of arm 403 is securely attached to the proximal end of proximal flexible member 406. A gripping tool 410 is attached to the distal end of the distal flexible member 407. As more clearly shown in FIG. 8B, the gripping tool 410 includes upper and lower jaws 412 and 414 connected to a jaw housing 416, where the base 418 of the housing 416 is distal. The flexible member 407 is firmly fixed to the distal end.

  More particularly, jaw housing 416 includes opposing parallel extending walls 420 and 422, with the proximal ends of jaws 412 and 414 positioned between the walls. As can be seen most clearly in FIGS. 8B-11B, each jaw is provided with a slot that accommodates a pin that spans the space between the two walls. Specifically, the upper jaw 412 includes slots 452 and 456 for receiving pins 423 and 424, respectively. Lower jaw 414 includes slots 454 and 458 that receive pins 425 and 426. Each jaw slot is oriented at an angle with respect to the grip on the distal side of the jaw and is substantially parallel to each other over most of the total length of each slot. However, as can be seen in particular with respect to FIGS. 10B and 11B, both slots 452 and 454 have proximal ends 453 and 455, respectively, that deviate from being parallel to slots 456 and 458, respectively. This has an important effect on jaw movement, as described in more detail below. Further, the jaws 412 and 414 include notches 457 and 459, with the notch 457 positioned between the slots 452 and 456 in the jaw 412 and the notch 459 between the slots 454 and 458 in the jaw 414. positioned. These notches 457 and 459 receive pins 424 and 426, respectively, when the jaws are in the closed position (see FIG. 9B). Further, jaws 412 and 414 are pivotally connected to link arms 436 and 438, respectively, and then the other end of link arms 436 and 438 is also located within housing 416 between walls 420 and 422. To the cable end terminal 430. An operation cable 432 is connected to the cable end terminal 430 and terminates in the cable end terminal 430, which itself passes through the jaw housing 416 and further extends through the flexible member 407 and the elongated shaft 405 (shown in the figure). The other end is terminated at the arm 404 of the handle 402 at the other end. A biasing spring 434 is disposed between the cable end terminal 430 and the base 418 of the jaw housing 415 with its axis coinciding with the cable 432. The jaws 412 and 414 themselves have opposing jaw surfaces 442 and 444, respectively. Each of the jaw surfaces is provided with grooves 446 and 448, respectively, that can accommodate an energy source suitable for tissue ablation, for example.

  An important advantage because the jaw configuration and jaw housing connection allow jaws to move in a non-parallel manner in the second range of motion while allowing parallel movement of the jaw in the first range of motion Has brought. The full range of this movement can be observed by referring to FIGS. 9-11, where the movement of such movement from the closed jaw position (FIGS. 9A and 9B) to the first open position (FIGS. 10A and 10B). It is possible to exercise while keeping parallel to each other throughout. The jaw can then move in a non-parallel manner from this first open position to a second open position (FIGS. 11A and 11B). In this second open position, the distal ends of the jaws extend more widely from each other than the proximal end of the jaws, and the jaws at the tip are similar to the openings that occur in the jaws connected by a single pivot point. Creating a larger opening in between. This larger opening is advantageous because it facilitates movement of the jaw near the target tissue or body structure. At the same time, as the jaws close from the first open position (FIGS. 10A and 10B) to the closed position (FIGS. 9A and 9B), the jaws keep parallel movement relative to each other, which is when the jaws are closed to the target tissue. It provides various advantages such as a uniform force distribution throughout. In addition, when the energy source is attached to the jaw, for example for ablation, the translation of the jaw allows more uniform energy transfer to the tissue over the length of the jaw, making it more uniform and consistent Can bring about ablation.

  The full range of this movement is achieved as follows. As can be seen, a biasing spring 434 is positioned to continuously bias the jaws away from each other in the open position. The spring bias is overcome by moving the handle 402 to translate the cable 432 and the cable end 430 connected to the cable toward the proximal end of the instrument, and the jaws are shown in FIGS. 9A and 9B. Can be moved to the closed position. When the cable tension is released, the jaws are biased to open from the closed position to the first open position (FIGS. 10A and 10B), but the slots 452, 456 and 454, 458 are pins 423, 424 and 425, respectively. To translate relative to 426, the upper and lower jaws 412 and 414 translate in a direction parallel to slots 452, 456 and 454, 458, respectively, so that the jaws remain parallel. During this range of movement, the ends of link arms 436 and 438 connected to cable termination 430 also translate, but forces that can be applied by the link arms to cause non-parallel movement are parallel. This is overcome by the restraining forces of the pins 423, 424 and 425, 426 held in the respective slots 452, 456 and 454, 458, respectively. However, when the jaws are further opened by bias, the pins 423 and 425 are relatively parallel to the ends 453 and 455 of the slots 452 and 454, respectively, deviating from parallel to the respective slots 456 and 458, respectively. Moving. The relative movement of the pin to these non-parallel sites allows the link arms 436 and 438 to pivot and translate, and when the jaw moves to the second open position (FIGS. 11A and 11B) A spreading movement of the jaws 412 and 414 relative to each other is provided.

  In yet a further variation, the articulation mechanism and flexible segment of the present invention can be combined with a catheter and used to guide the catheter. As shown in FIGS. 16A and 16B, the catheter 700 integrates the articulation mechanism with the distal end 702 of the mechanism integral with the distal end of the catheter and the proximal end formed by the flexible member 704 with the handle 706. It is drawn from The proximal end flexible member 704 is formed of flexible segments 711, 713, and 715 similar to the flexible segments described herein. Distal end portions 712, 714, and 716 are integrally formed portions of the distal end 702 of the catheter. To guide the catheter 700 during advancement, a cable set (not shown) allows distal end segments 712, 714, and 716 to proximal end segments 711, 713, and 715. The distal end 702 is connected remotely by manipulating the flexible member 704. As can be seen more clearly in FIG. 16B, the distal end of the catheter 700 is a catheter tube with a central lumen 724 that extends further through the entire length of the catheter to separate the distal and proximal segments. A catheter tube is provided with a plurality of cable passages 728 that can accommodate a set of cables to connect (not shown). The central lumen can provide, for example, the passage of wires, energy sources, or other control elements to the catheter tip, can act as a through-hole for the passage of fluids, or can be otherwise catheterized A known function of the lumen can be provided. The cable is as described in US patent application Ser. No. 10 / 444,769, which is the same as the present application and is pending at the same time and is incorporated herein by reference in its entirety. Can be secured in the catheter tube at the desired location. Each segment at the distal end of the catheter can be formed of a material having a variety of durometers and / or various types so as to provide an additional level of control when manipulating the catheter. It may be length. For example, if the most distal site is a lower durometer than the most proximal site, the cable force required to articulate the most distal site is the most proximal The controllability of the distal end is improved because it is smaller than the force required to articulate the side part. In other embodiments, the distal end segments are formed of individual sections of catheter tube material that abut one another and are positioned relative to one another by passing a cable set and securing within the sections. Can be maintained. Additionally, the catheter 700 includes a proximal end flexible member 704 formed of the flexible segment described herein, but alternatively the proximal end is similar to the distal end by a cable set. It is further conceivable to form with a wide variety of articulation link systems connected to the. Such an articulation link system is not limited to these, but the present application and the owner are the same and are pending at the same time, the entirety of which is incorporated herein by reference. US patent application Ser. Nos. 10 / 444,769 and 10 / 928,479.

  12 and 13 illustrate a flexible segment according to another embodiment of the present invention. As shown in FIG. 12, the flexible segment 500 includes two charge items 506 and 508 connecting the links 502 and 504; otherwise, a number of features of the flexible segment described above. Share. A cable passage 512 is provided to receive and pass the cable to control the segment itself or other segments. In addition, a central passage 510 is also provided. As shown in more detail in FIG. 13, the flexible segment 500 is formed of two components, an inner core 520 and an outer cover 540. Forming the flexible segment with components of an inner core and an outer cover provides manufacturing advantages as described in more detail below. The inner core 520 is configured to be accommodated in the axial direction inside the outer cover 540. The inner core 520 includes link portions 522 and 524 that are each generally cylindrical. Flexible hinge portions 526 and 528 connect each link portion to wing portions 534 and 536, and wing portions 534 and 536 are united and aligned with the two link portions between the two link portions. Is formed with another generally cylindrical portion, which is combined with the link to provide a central passage 510 of the flexible segment 500 after formation. The inner core further includes alignment flanges 530 and 532 that extend longitudinally along the outer surface of the core. Similarly, the outer cover 540 also has link portions 542 and 544 that are also generally cylindrical. Flexible hinge portions 546 and 548 connect each link portion to stem portions 554 and 556 that are aligned between the two link portions and disposed between the two link portions. A series of cable grooves 558 extend longitudinally along the inner surface 549 of the outer cover. The outer cover 540 further includes alignment grooves 550 and 552 that extend longitudinally along the inner surface of the cover, with the grooves 550 extending particularly along the stem portions 554 and 556. When the inner core and the outer cover are assembled together, the grooves and the grooves of the inner core and the outer cover are aligned with each other and the flexible hinge 500 is aligned with each other. Receiving alignment flanges 530 and 532 of inner core 520, respectively, to form a flexible hinge and cable passageway 512. Specifically, link portions 522 and 542 form link 502, flexible hinge portions 526 and 546 form flexible hinge 506, flexible hinge portions 528 and 548 form flexible hinge 508, and the link. Portions 524 and 544 form a link 504. The outer surface of the inner core 520 is in contact with the inner surface of the outer cover 540, and the cable groove 558 is sealed in the longitudinal direction to form a cable passage 512.

  In flexible segments and flexible members formed by a molding process, the manufacture of components such as the inner core and outer cover is easier and more efficient than manufacturing the flexible segment or flexible member as a single component. Can be an economic process. For example, to mold a flexible segment with a cable passage as a single component, it is necessary to use a number of small core pins that extend the entire length of the part as part of the molding process. Molding the outer cover component with the cable groove is a simpler process because the mold cavity itself provides the groove. Further, the embodiment depicted in FIGS. 12 and 13 is a double or dual bending hinge link segment, but is not limited to other links described herein, It will be readily appreciated that a wide variety of flexible hinge links, segments, and flexible members, such as segments and members, can be formed from the components of the inner core and outer cover. In addition, other links and link systems can be formed with components, an inner core and an outer cover, as well.

  This unique configuration of the flexible segment 500 also achieves other advantages. In particular, the double hinge configuration of the flexible segment 500 is the same as the present application and is pending at the same time, and is hereby incorporated by reference in its entirety. Similar to the aspect provided by the neutral cable bias dual pivot link system described in 10 / 928,479, it provides a neutral cable bias. Referring to FIG. 12, at the position where the flexible hinges 506 and 508 generally coincide with the opposing surfaces of each link 502 and 504, i.e. the position where the operating cable coincides with the cable path exit point exiting the respective link, bending or bending. Will be understood. When the flexible segment is manipulated to the desired position or configuration, each flexible hinge will deflect or bend so that the two links are centered around the double hinge or away from each other. Furthermore, as a result of the bending action of such a double hinge, as with the flexible segment of the neutral cable bias described above, a given cable path exit point of one link is the corresponding cable path of the other link. The distance traveled towards the exit point is equal to the distance traveled so that the opposite cable path exit point on the opposite side of the link is away from the corresponding cable path exit point on the other link. However, the combinatorial distance between the two respective sets of cable path exit points remains constant regardless of whether the segment is deflected, which is important for maintaining a neutral cable bias. If the distances of such combinations are not equal, increased cable sagging or tension can occur. Specifically, when the link is deflected, cable pull may occur if the distance of the combination between the set of opposing passage exit points is greater than the distance of the combination in a straight unbent position. On the other hand, when bending or bending, the cable may sag if the distance of the combination between the set of opposing passage exit points is reduced compared to a straight unbent position.

  Other advantages provided by the configuration of the flexible segment 500 include wings 536 and 534 that can function as stops to prevent excessive bending of the hinge region. When the flexible segment 500 undergoes bending or deflection, the opposing surfaces of the links 502 and 504 move toward each other until they contact one or the other wing and further bending motion is restricted. Thus, for example, in a flexible segment designed to have a maximum total bending angle of 60 °, the wings are configured to limit each flexible hinge to a maximum of 30 °. This will be explained more clearly with reference to FIGS. 14 and 15 depicting a flexible segment 600 that is similar to the flexible segment 500 but is a single unit configuration. Similar to flexible segment 500, flexible segment 600 includes two links 602 and 604 connected by flexible hinges 606 and 608. A cable passage 612 is provided for receiving and passing the cable, and a central passage 610 is further provided. More specifically, flexible hinges 606 and 608 connect links 602 and 604, respectively, to wings 624 and 626 that are disposed between and aligned with the two links. Further, stem portions 614 and 616 extending longitudinally from the wing are aligned with the links 602 and 604 and connected to the links 602 and 604. As most clearly shown in FIG. 15B, the wing 624 functions as a stop to limit further bending of the flexible segment 600.

  The present invention further contemplates a kit for providing various articulation mechanisms and associated accessories. For example, kits can be provided that include articulation mechanisms having different lengths, different segment diameters, and / or different types of tools or instruments. The kit may optionally include various types of fixation rods or plastic covers. In addition, kits can be tailored to specific applications. For example, a kit for a surgical application can be configured, for example, for endoscopy, suck back, or catheter placement and / or configured for a particular patient population, such as a child or adult can do.

  All publications, patents, and patent applications cited herein are hereby specifically incorporated by reference for each purpose, as if each individual publication, patent, and patent application was specifically and individually listed. To the same extent as indicated to be incorporated, the entirety of which is incorporated herein by reference. The present invention has been described in some detail by way of illustration or illustration for the purpose of facilitating understanding, but without departing from the spirit and scope of the appended claims in light of the teachings of the invention. Those skilled in the art will readily understand that several modifications and variations are possible.

Claims (6)

Surgical device, which:
A proximal flexible segment comprising a pair of proximal links connected by a proximal flexible hinge, each proximal link having a first diameter and a plurality of spaced apart A proximal flexible segment including a cable passage;
A distal flexible segment comprising a pair of distal links connected by a distal flexible hinge, each of the distal links having a second diameter and a plurality of spaced apart A distal flexible segment comprising a cable passage, wherein the second diameter is different from the first diameter; and the proximal flexible segment and the distal flexible segment A plurality of cables coupled to each cable extending through one of the cable passages in each of the side links and through one of the cable passages in each of the distal links, A surgical device comprising a plurality of cables, wherein movement of the flexure segment causes corresponding movement of the connected distal flexure segment. The surgical apparatus according to claim 1, further comprising a tapered spacer element between the proximal flexible segment and the distal flexible segment. Before SL plurality of cables is Ru through the spacer element, the surgical device according to claim 2. The central longitudinal axis proximal flexible segment extending through said distal flexible segment, and said spacer, and said plurality of cables that exit Ri through the space Sa is not parallel to the central longitudinal axis, wherein Item 4. The surgical device according to Item 3. The proximal flexible hinge and the distal flexible hinge are oriented parallel to each other along a central longitudinal axis through the proximal flexible segment and the distal flexible segment and the corresponding The surgical apparatus according to claim 1, wherein the movement is a two-dimensional movement. The movement of the proximal flexible segment causes a first angle between the proximal links and a second angle between the distal links, the first angle and the The surgical apparatus according to claim 1, wherein the second angles are different.

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